Heart valve prosthesis anchored to interventricular septum and conveying and releasing method thereof

ABSTRACT

A heart valve prosthesis anchored to an interventricular septum. The heart valve prosthesis includes a valve supporting frame and a fixing device. The valve supporting frame includes a valve stitching section and an artificial valve, and the artificial valve is fixedly connected to the valve stitching section; the fixing device includes a fixing and supporting section and a fixing member, one end of the fixing and supporting section is connected to a proximal end of the valve stitching section, and another end of the fixing and supporting section is connected to the interventricular septum of a patient by the fixing member, to support the heart valve prosthesis and prevent the heart valve prosthesis from axially moving.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 16/343,937, filed on Apr. 22, 2019, which is a National stageof International Application No. PCT/CN2017/107381, filed on Oct. 23,2017. The International Application claims priority to Chinese PatentApplication No. 201610921114.9, filed on Oct. 24, 2016. Theafore-mentioned patent applications are hereby incorporated by referencein their entireties.

TECHNICAL FIELD

The present application relates to the field of medical equipment, andparticularly relates to a heart valve prosthesis anchored to aninterventricular septum and a conveying and releasing method thereof.

BACKGROUND

Mitral valve is located at the left atrioventricular orifice, andincludes five parts: valve annulus, valve leaflet, chordae tendineae,papillary muscle and commissure, and the mitral valve's accurate name inanatomia is mitral apparatus or mitral complex. Mitral valve annulus isa fibrous tissue strip attached to the edge of the left atrioventricularorifice, and is in an irregular “D” shape. The front one third of themitral valve annulus is a continuation of the anterior valve and theaorta, the angles formed between the atrium corresponding to theanterior leaflet and the mitral valve are different from the anglesformed between the atrium corresponding to the posterior leaflet and themitral valve annulus, and the atrium includes the left atrial appendage.Mitral valve dysfunction is one of the most common heart diseases, suchas mitral insufficiency caused by mitral valve prolapse, mitral stenosiscaused by valve lesion due to rheumatic inflammation.

Mitral insufficiency can be classified into three types: functional,degenerative and mixed mitral insufficiency. The most common ones aredegenerative mitral insufficiency and functional mitral insufficiency.The functional mitral insufficiency is generally secondary to motorfunction impairment of left ventricular wall, left ventricle dilatationand papillary muscle dysfunction, and is common in patients of heartfailure. Such patients also include the ones of ischemic mitralinsufficiency secondary to coronary heart disease and mitralinsufficiency related to non-ischemic cardiomyopathy. Degenerativemitral valve reflux diseases are generally considered as thepathological changes of the valve structure or the pathological changesof the subvalvular structure, including the abnormal extension orrupture of the chordae tendineae.

Mitral stenosis is the most common type of rheumatic valvular heartdiseases, in which 40% of the patients have simple mitral stenosis.Because of the recurrent rheumatic fever, the mitral stenosis in theearly stage is mainly caused by edema, inflammation and neoplasm(exudate) of the valve commissure and its basis points, and in the laterhealing process, because of the sediment of fibrous protein and fibrouschanges, gradually formed are adhesion and fusion of the boundarybetween the anterior and posterior valve leaflets, valve thickening,valve coarsening, valve sclerosis, valve calcification, and chordaetendineae shortening and adhesion, which limit the mobility and openingof the valve, and cause valve orifice stenosis. Other rare etiologiesinclude senile mitral valve annulus or sub-annulus calcification,congenital stenosis and connective tissue diseases and so on.

Tricuspid valve is located at the right atrioventricular orifice. Acommon disease of the tricuspid valve is tricuspid insufficiency, thatis, in the contraction period, the blood flows back from the rightventricle into the right atrium, which causes the excessive dilatationof the right atrium, increased pressure, and backflow disorder of venousblood. Because of the increasing load, a compensation on the rightventricle occurs. As a result, the right ventricle becomes fat andthick, and right heart failure easily happens.

Tricuspid regurgitation is generally caused by pulmonary arterialhypertension, right ventricular dilatation and tricuspid valve annulusdilatation. Clinically the expression of the etiologies (such as leftheart failure and pulmonary arterial hypertension) of tricuspidregurgitation is common, and once tricuspid regurgitation arises, thesymptoms of right heart failure such as fatigue, ascites, edema,hepatalgia, dyspepsia and anorexia are aggravated. Mild tricuspidregurgitation does not have obvious clinical symptoms, but operativetreatment is required for serious tricuspid regurgitation.

The traditional treatments for the diseases of mitral valve andtricuspid valve include medication for mild to severe regurgitation, andsurgical methods having the corresponding operation indications.Wherein, the surgical methods further comprise valve replacement andvalve repairment. In the surgical methods, the typical thoracotomy andopen heart surgeries have too large invasiveness, and an extracorporealcirculation needs to be established, therefore, there will be a highcomplication incidence and a risk of infection. Many patients cannotbear the huge surgical risk and have to helplessly wait for death.

Since the report of the first surgery of aortic valve intervention andreplacement, many corporations have made a lot of efforts in thetechnique of aortic valve intervention, and the technique is becomingincreasingly mature. However, as for the intervention treatment ofatrioventricular valve, a relatively large blank still exists in theart. A few products for the intervention treatment for atrioventricularvalve are applied in transcatheter intervention valve shaping andrepairment, but in the aspect of transcatheter intervention valvereplacement, no mature products are available in the world. What listedas follows are several kinds of technique for transcutaneousintervention valve replacement of mitral valve, which are mostly in thestage of animal experiments or clinical trials, and all have theirindividual limitations.

The Chinese patent publication No. CN102639179B and the U.S. Pat. No.8,449,599 describe a prosthetic apparatus for mitral valve replacementof the Edwards Lifesciences Corporation. The prosthetic apparatus isconfigured to be implanted into the native mitral valve region of theheart; the native mitral valve has a native annulus and a native valveleaflets. The prosthetic apparatus includes a tube-shaped main body. Thetube-shaped main body includes a lumen, an atrium end and a ventricleend, which are configured to allow the blood to flow through, and isconfigured to be placed within the native annulus. The main body may beradially compressed to be in a radially compressed state, so as to bedelivered into the heart, and be self-expandable from the compressedstate to a radially expanded state. The prosthetic apparatus furtherincludes at least one fixing device connected with the main body anddisposed outside the main body. The fixing device and the main body areconnected, so that when the main body is in the expanded state, the atleast one fixing device is configured to hook the periphery of thenative leaflets, to limit a leaflet receiving space between at least onefixing device and the main body. The prosthetic apparatus furtherincludes an annular flange portion extending radially outward from anatrial end of the main body, and the annular flange portion comprises anatrial sealing member that blocks blood from flowing beyond the atrialend of the main body disposed outside the main body when the prostheticapparatus is implanted. Regarding the fixing mode employed by thetechnique, because the fixing device defined in the independent claim isdisposed outside the main body, the native leaflets will be smoothlyplaced between the exterior side surface of the blood channel of themain body of the supporting frame and the inner side surface of theanchoring device, thus the fastness of the fixing completely relies onthe friction between the fixing device and the main body. Furthermore,after being clamped, the native valve is always in the valve leafletopening position and spreading state of the diastole period, and thelarge area annular blocks the blood flow in the left ventricular outflowtract, thus the blood that should flow from the left ventricle into theaorta during this period is partially blocked and flows back to the leftventricle. After long-term implantation, disorders such as heart failurewill arise. Especially when the native valve leaflet of the patient hassevere calcification, the valve clamping mechanism of the native valveleaflet increases the difficulty of the surgery operation. In theclinical application of this product of Edwards, the native valveleaflet of the patient were not able to be correctly grabbed, whichcauses multiple cases of surgery failure, instrument displacement andurgent transferring the patients to surgical thoracotomy operationnative valve, and the patients finally died or were faced with the riskof death. Finally, the technique of clamping the native valve leafletinevitably affects the function of the supporting frame of returning tothe sheath, and once released, it cannot be withdrawn, which brings alarge operation risk.

The Chinese patent No. CN201180020556 introduces a mitral valveprosthesis of Medtronic corporation, which comprises an inner supportingstructure that has a downstream section and an upstream section, whereina cross-sectional area of the upstream section is greater than that ofthe downstream section, and the inner supporting structure is configuredto be at least partially positioned on the atrial side of the nativevalve complex, and to exert an axial force toward the left ventricle;and an outer supporting structure, having two or more engagement armsattached to the inner support structure. Wherein, the prosthesis, afterbeing transplanted, is configured to clamp part of the leaflet of theprotogenetic valve between the inner supporting structure and theengagement arms. As similar to the design of Edwards, the upstreamsection having a greater cross-sectional area abuts on the mitral valveannulus, and the engagement arms of the outer supporting structure grabthe native mitral valve of the patient. The supporting frame as a wholeis a cylindrical symmetrical structure, so doctors are still required toselect a valve with a higher specification in surgery to provide asufficient supporting force. The valve with huge diameter severelyblocks the blood supply from the left ventricular outflow tract, and inthe aortic valve orifice, the flow rate is increased and the pressure isboosted, which, for a long time, easily causes heart failure. Moreover,the valve with relatively large diameter entirely clings to the valveannulus directly, and will press the adjacent tissues including theaortic valve annulus.

The Chinese patent No. CN201610074782 provides a D-shapedintervention-type artificial heart valve, comprising a supporting frame,a valve leaflet provided on the inner side of the supporting frame, anda covering film provided on the supporting frame body wall. Thesupporting frame comprises a first sub-supporting frame, a secondsub-supporting frame and a third sub-supporting frame that aresequentially connected. The first sub-supporting frame is a net-liketube; the second sub-supporting frame is a net-like tube whosecross-section is D-shaped; and the third sub-supporting frame is anet-like tube with a horn shape. The maximum tube diameter of the firstsub-supporting frame is the same as the tube diameter of the secondsub-supporting frame, and the minimum tube diameter of the thirdsub-supporting frame is the same as the tube diameter of the secondsub-supporting frame. Although the patent states that the so-calledD-shaped net-like tube may match with the shape of the receiving spacethat is enclosed by the protogenetic body wall of the in-situ mitralvalve, and compared with a supporting frame whose cross-section iscircular, the D-shaped net-like tube may avoid the narrowing of theoutflow tract of the heart caused by the excessive stress exerted on thenon-round contour of the mitral valve by the supporting frame, theproblems of the technique are that, even if the cross-section of thesupporting frame is modified to be D-shape, the direct contact of thewhole lattice structure with the mitral valve annulus still exertsstress on its surrounding tissue; moreover, in the technical solution,the maximum tube diameter of the first sub-supporting frame is the sameas the tube diameter of the second sub-supporting frame, which meansthat the diameter of the cross-section of the supporting frame is stillat least equal to the diameter of the mitral valve annulus, therefore,the influence exerted on the outflow tract by the huge supporting frameitself still exists; and finally, in the technical solution, the secondsub-supporting frame is configured to be D-shaped, and the valve leafletis stitched to the supporting frame, and the non-round region definitelyaffects the clinging state after the valve leaflet is stitched. Althoughthe technique does not particularly disclose the stitching mode of thevalve, it can still be seen from the drawings that the valve leaflet isa three-leaf valve. Therefore, the non-round suture will be harmful tothe closing property of the valve leaflet and long-term valve leafletfatigue.

The U.S. patent publication No. US20160074160 discloses a valvesupporting frame structure, comprising an expanded external supportingframe made of a shape memory alloy, and an internal supporting framemade of a shape memory alloy; wherein the internal supporting frameincludes two portions, and in an initial state, the first portion is anexpanded structure, and the second portion is a compressed structure; anartificial valve is provided at the first portion of the internalsupporting frame, and the second portion is provided with a string; andthe internal supporting frame and the external supporting frame areconnected and fixed. The problems of the solution are that, the expandedexternal supporting frame still supports and radially expands theoriginal valve annulus, and the relatively large cross-sectional area ofthe supporting frame definitely takes effects on the outflow tract. Inaddition, the portion of the external supporting frame that is disposedon the mitral valve annulus cannot conform to the non-uniform contour ofthe atrial wall or of the native valve annulus of the patient, pressingthe aorta or other heart tissues, and moreover, the leak resistanceeffect is poor.

The current clinical results indicate that, there are no ideal productsfor valve intervention and replacement of atrioventricular valve. Themajor reason is that, both of the mitral valve and the tricuspid valvehave particular physiological structures, and the physiologicalenvironments under the valve annulus are complicated, which makes itdifficult to accurately position and fix the products. The problems ofthe prior art are summarized as follows: (1) the conventional anchoringtechniques mostly rely on the supporting force exerted on theatrioventricular valve annulus by the supporting frame; and doctorsusually select a valve specification larger than the valve annulus ofthe autogenous atrioventricular valve of the patient, so as to conformto the contour of the mitral valve tissue, thus the huge supportingframe itself not only affects the outflow tract, but also easily pressesthe surrounding tissues, and further blocks the blood flow in the leftventricular outflow tract; (2) in the prior art, the supporting frameportion disposed in the atrium mostly configured to be a lattice, thehuge supporting force of which easily presses the heart tissue; and (3)as for the mitral valve replacement, the supporting frame specificationis too large, and the anterior valve of the mitral valve is easilypushed toward the left ventricular outflow tract; and the design ofclamping the valve leaflet, which is introduced to fix the anteriorvalve of the mitral valve, makes the releasing step extremelycomplicated and be influenced by the calcification degree of the valveleaflet, which affects the success rate of the operation.

In conclusion, although the above described techniques individually havecertain effects on the atrioventricular valve replacement, they stillhave defects. In the field of surgical treatment for valve lesion, anovel heart valve prosthesis is urgently needed to solve the aboveproblems.

SUMMARY OF THE DISCLOSURE

The objective of the present application is to overcome the defects inthe prior art. For the patients that require intervention valvereplacement due to mitral valve or tricuspid valve insufficiency orstenosis, the present application provides a heart valve prosthesisanchored to an interventricular septum, and a conveying and releasingmethod of the heart valve prosthesis. The present application solves theproblems of the anchoring technology in the prior art, which are causedby radially dilating the native valve annulus of the patient, and on thebasis of ensuring the anchoring effects of the implanted valve, mayreduce the influences on the outflow tract after the supporting frame isreleased, and avoids the traction for the valve annulus of the nativevalve.

An objective of the present application is achieved by the followingtechnical solution:

a heart valve prosthesis anchored to an interventricular septumcomprises a valve supporting frame and a fixing device; the valvesupporting frame comprises a valve stitching section and an artificialvalve; the artificial valve is fixedly connected to the valve stitchingsection; the fixing device comprises a fixing and supporting section anda fixing member; one end of the fixing and supporting section isconnected to a proximal portion of the valve stitching section; andanother end of the fixing and supporting section is connected to aninterventricular septum of a patient by the fixing member to support theheart valve prosthesis and limit axial movement of the heart valveprosthesis.

The objectives of the present application may also be further realizedby following technical solutions:

Preferably, the fixing and supporting section is provided with a curvedsection, which is configured to enable a proximal portion of the fixingand supporting section to cling to the interventricular septum of thepatient. More preferably, the part of the fixing and supporting sectionthat contacts the interventricular septum of the patient is a straightline section.

Preferably, the fixing and supporting section comprises a plurality ofrods or wires; one end of each of the plurality of rods or wires isconnected to the valve stitching section; and another end of each of theplurality of rods or wires is connected to the interventricular septumof the patient by the fixing member.

Preferably, the fixing and supporting section comprises a plurality ofrods or wires; one end of each of the plurality of rods or wires isconnected to the valve stitching section; and other ends of theplurality of rods or wires are mutually connected and are connected tothe interventricular septum of the patient by the fixing member.

More preferably, on the circumferential circular arc where the outeredge of the valve stitching section is located, the largest arc lengththat is formed by the connection points between the plurality of rods orwires and the valve stitching section is greater than or equal to aquarter of the perimeter of the valve stitching section.

Preferably, the fixing and supporting section is formed by extending askeleton of a proximal end of the valve stitching section.

Preferably, the fixing and supporting section is covered with a film.

Preferably, the fixing and supporting section is a triangular structure,or the fixing and supporting section is an arcuate structure, or thefixing and supporting section is a net-like structure. More preferably,the fixing and supporting section is provided therein with an enhancingrod.

Preferably, the fixing and supporting section and the fixing member arean integral structure, and the fixing member is barbs, or the fixingmember is a sharp structure.

Preferably, the fixing device comprises a fixing member pushing system,and the fixing member pushing system pushes the fixing member so thatone end of the fixing and supporting section is fixed on theinterventricular septum of the patient.

Preferably, the fixing member is an anchoring needle, and the tailportion of the anchoring needle is provided with a stopper.

More preferably, the fixing member pushing system comprises a guide railand a mandril; the guide rail is provided on the fixing and supportingsection; the ends of the guide rail have a necking; the anchoring needleand the mandril are provided within the guide rail; by operating themandril, the needle point portion of the anchoring needle passes throughthe guide rail and is inserted into the interventricular septum of thepatient; and the diameter of the stopper is greater than the caliber ofthe necking.

More preferably, the stopper is provided with a connector, and theconnector is a wire-shaped member; one end of the connector is connectedto the fixing and supporting section, and the other end of the connectoris connected to the stopper. Such a design mainly can ensure that theimplanting instrument is detachably connected with the pushing system,thereby improving the accuracy of the needle inserting, and preventingthe anchoring needle from deviating from the predetermined needleinserting point.

Preferably, the fixing and supporting section is an inverted cone-shapedstructure; one end of the fixing and supporting section, which has alarger diameter, is connected to the proximal end of the valve stitchingsection; one end of the fixing and supporting section, which has asmaller diameter, is connected to a connecting rod; the connecting rodis rigid; a fixing member is arranged at the proximal portion of theconnecting rod; and in a free state, the fixing member is fixed on theinterventricular septum.

More preferably, the proximal portion of the connecting rod is a hollowtube; the tube wall is provided with an opening; and in a free state,the furthest distal end of the fixing member protrudes out of theopening on the hollow tube and inserts into the interventricular septum.The furthest distal end of the fixing member is sharp, and the distalportion of the fixing member is pre-shaped. The distal portion of thefixing member is pre-shaped to be one of or a combination of thefollowing shapes: spiral, circle, arc, a combination of arc and straightline, branched double hooks, three-dimensional bent shape andmultisection bent shape, and the distal end of the fixing member doesnot have a barb or has one or more barbs.

Preferably, the fixing member is a supporting frame having two largerend portions and a smaller middle portion, and is formed by a shapememory alloy.

Preferably, the heart valve prosthesis further comprises an auxiliaryfixing device; one end of the auxiliary fixing device is connected to adistal end of the valve stitching section, and the other end of theauxiliary fixing device is fixed on an atrium tissue or fixed in a bloodvessel of the patient.

More preferably, the auxiliary fixing device is a rod or a wire, or theauxiliary fixing device is a supporting frame.

Preferably, the heart valve prosthesis further comprises an auxiliarystabilizing device; a proximal end of the auxiliary stabilizing deviceis connected to the fixing and supporting section, or a proximal end ofthe auxiliary stabilizing device is connected to the fixing member, anda distal end of the auxiliary stabilizing device is connected to thevalve stitching section.

More preferably, the auxiliary stabilizing device is a wire or a rod.

Preferably, in a longitudinal section parallel to a central axis of theartificial valve, the projections of the valve stitching section, of thefixing and supporting section and of the auxiliary stabilizing deviceare connected to become a closed structure.

Preferably, in a cross-section perpendicular to a central axis of theartificial valve, a cross-sectional area of the valve stitching sectionis less than a cross-sectional area of a native valve annulus of thepatient, which prevents the valve stitching section radially dilatingthe native valve annulus of the patient.

Preferably, the heart valve prosthesis further comprises a ring; thering is connected to the valve stitching section, and in a free state,the ring is disposed in an atrium of the patient.

Preferably, the ring clings to a native valve annulus of the patient.

Preferably, and in a free state, a cross-sectional area of the ring isgreater than a cross-sectional area of a native valve annulus of thepatient, and the ring is capable of conforming to a non-uniform contourof an atrial wall or of the native valve annulus of the patient and notrestricting a contraction function of the atrium.

Preferably, in a cross-section perpendicular to a central axis of theartificial valve, the projection of the ring is a ring-shaped structure;the ring-shaped structure comprises a circular structure, an ellipticstructure or a D-shaped structure; and the valve stitching section isdisposed in the ring.

Preferably, in a cross-section perpendicular to a central axis of theartificial valve, a center of the valve stitching section and a centerof the ring are not coincident.

More preferably, when the heart valve prosthesis is used for mitralvalve intervention and replacement, the central axis of the valvestitching section deviates toward the posterior valve region of themitral valve of the patient.

More preferably, when the heart valve prosthesis is used for tricuspidvalve intervention and replacement, the central axis of the valvestitching section deviates toward the cuspis medialis region of thetricuspid valve of the patient.

Preferably, in a longitudinal section parallel to a central axis of theartificial valve, the projection of the ring is a disk-like structure ora bowl-like structure.

Preferably, the valve stitching section is a tube-like latticestructure, or the valve stitching section is a tube-like wave-shapedstructure.

Preferably, a distal skeleton of the valve stitching section is providedwith an extended section. Such a design enables the supporting frame tobe controllably released. More preferably, the extension section and thevalve stitching section are detachably connected. Such a design ensuresthat the extension section can be withdrawn from the human body whilethe supporting frame is ensured to be controllably released, therebygreatly reducing the implant, reducing the contact and stimulation tothe atrium, and eliminating the limitation to the valve-in-valveimplantation in future.

Preferably, the proximal skeleton of the valve stitching section ispartially extended. Such a design enables the ring to expand firstlywhile the proximal end of the supporting frame remains compressed, whichfacilitates adjusting the position of the supporting frame, therebypreventing the proximal end of the supporting frame from stabbing theblood vessel wall due to expanding in the adjusting process.

Preferably, the ring has a skeleton made of a shape memory alloy; theskeleton is partially or entirely covered with a film, and the filmmaterial comprises metal material, polytetrafluoroethylene,polyethylene, polypropylene, terylene or animal-derived material.

More preferably, the skeleton includes a plurality of supporting rods;or the skeleton is a wave-shaped structure, a saw-shaped structure or alattice structure that is formed by winding a metal memory materialwire. The width of the supporting rods or the diameter of the metalmemory material wire (for example, a nickel titanium alloy wire) is inthe range of 0.1 -0.6 mm.

Preferably, the ring is provided with a barb, and in a free state, thebarb is inserted into an autologous tissue of the patient.

Preferably, the ring and the valve stitching section are made separatelyand independently and then are connected to form an integral structure.

Preferably, the ring and the valve stitching section are an integralstructure, and the ring is formed by part of the rods in the skeleton ofthe valve stitching section.

Preferably, an outer surface of the valve stitching section is furtherprovided with a filling device.

Preferably, the filling device has a skeleton made of a shape memoryalloy; the skeleton is partially or entirely covered with a film; andthe film material comprises metal material, polytetrafluoroethylene,polyethylene, polypropylene, terylene or animal-derived material.

Preferably, in a cross-section perpendicular to a central axis of theartificial valve, the projection of the filling device is a ring-shapedstructure, and the ring-shaped structure comprises a circular ringstructure or a D-shaped ring structure.

Preferably, the filling device and the ring are an integral structure.

Another objective of the present application is realized by thefollowing technical solutions:

a method for conveying and releasing the heart valve prosthesis anchoredto an interventricular septum comprises the following steps:

-   -   a. introducing a conveying conduit loaded with the heart valve        prosthesis to an atrioventricular valve annulus via a minimally        invasive incision in the atrial wall;    -   b. operating the conveying conduit, to release the fixing        device;    -   c. operating the conveying conduit, to release the valve        stitching section;    -   d. operating the conveying conduit, to make the fixing member be        inserted into the interventricular septum of the patient; and    -   e. withdrawing the conveying conduit from a human body.

Preferably, the method further comprises the following steps between thestep c and the step d:

-   -   c1. operating the conveying conduit, to partially release the        valve stitching section and make the valve stitching section not        be completely detached from the conveying conduit;    -   c2. operating the conveying conduit, to release the ring, and        positioning through the ring; and    -   c3. operating the conveying conduit, to completely release the        valve stitching section.

The advantages of the present application over the prior art are:

-   -   1. In the design of most of the products in the prior art, a        supporting frame supports the valve annulus; what different from        the prior art are that, in the present application, the fixing        and supporting section is fixed on the interventricular septum        of the patient by the fixing member, and such an anchoring mode        enables the supporting frame to obtain a anchoring force large        enough, without radially dilating the native valve annulus of        the patient.    -   2. In the present application, the fixing and supporting section        is provided with a curved section, thereby enabling the proximal        end portion of the fixing and supporting section to cling to the        interventricular septum of the patient, and the contact part of        the distal end of the fixing and supporting section with the        interventricular septum of the patient is a straight line        section. Such a design can increase the contact area between the        fixing and supporting section and the interventricular septum of        the patient to the utmost extent, thereby enhancing the        anchoring effect.    -   3. In the present application, on the circumferential circular        arc where the outer edge of the valve stitching section is        located, the largest arc length that is formed by the connection        points between the plurality of rods and the valve stitching        section is greater than or equal to a quarter of the perimeter        of the valve stitching section. The advantage of such a design        is that the fulcrum of the fixing and supporting section, which        is disposed on the valve stitching section, can provide        sufficient supporting strength and rigidity, thereby avoiding        the incline of the valve stitching section.    -   4. In the present application, the auxiliary fixing device is        provided. The auxiliary fixing device is fixed on the atrium        tissue or fixed in the blood vessel of the patient, and prevents        the displacement or disengagement of the implant by means of        upper and lower location limiting, thereby enhancing the        anchoring fastness of the implant.    -   5. In the present application, the auxiliary stabilizing device        is provided. In a longitudinal section parallel to a central        axis of the artificial valve, the projections of the valve        stitching section, of the fixing and supporting section and of        the auxiliary stabilizing device are connected to become a        closed structure, which enables the implant to be more secure in        the target position while ensuring the operation convenience of        fixing on one side, thereby preventing the heart valve        prosthesis from losing balance in the body of the patient.    -   6. As different from the concentric structure of most of the        conventional products in the prior art, in the present        application, in a cross-section perpendicular to a central axis        of the artificial valve, a center of the valve stitching section        and a center of the ring are not coincident. When the heart        valve prosthesis is used for mitral valve intervention and        replacement, the central axis of the valve stitching section        deviates toward the posterior valve region of the mitral valve        of the patient, which can further reduce the block to the left        ventricular outflow tract. When the heart valve prosthesis is        used for tricuspid valve intervention and replacement, the        central axis of the valve stitching section deviates toward the        cuspis medialis region of the tricuspid valve of the patient,        which facilitates the fixing and supporting section clinging to        the target anchoring region, thereby obtaining a more ideal        anchoring effect, and more stable movement of the valve.    -   7. What different from the design of most of the products in the        prior art, in which a supporting frame supports the valve        annulus, are that, in the present application, in a        cross-section perpendicular to a central axis of the artificial        valve, the projection area of the valve stitching section is        less than the projection area of the native valve annulus of the        patient, which prevents the valve stitching section radially        dilating the native valve annulus of the patient, thereby not        only reducing the influence on the outflow tract after the        supporting frame is released, and avoiding the traction to the        protogenetic valve annulus, but also ensuring that the opening        area of the valve will not change greatly because of the huge        difference between the annulus of patients, and optimizing the        performance of the valve. Moreover, the manufacturers may reduce        the product specifications, which alleviate the goods stocking        pressure of the manufacturers.    -   8. In the product in the prior art, the supporting frames        located in the atrium mostly employs the lattice form, and the        huge supporting force of the supporting frame easily presses the        heart tissue, and the leak resistance effect is unsatisfying.        What different from the supporting frame in the prior art are        that, the ring of the present application is disposed in the        atrium of the patient and clings to the native valve annulus of        the patient, and the ring may conform to the non-uniform contour        of the atrial wall or of the native valve annulus of the        patient, thereby improving the leak resistance effect.    -   9. In the present application, a distal skeleton of the valve        stitching section is provided with an extended section, and the        extended section and the valve stitching section are detachably        connected. Such a design ensures that the extended section may        be withdrawn from the human body while the supporting frame is        ensured to be controllably released, thereby greatly reducing        the implant, reducing the contact and stimulation to the atrium,        facilitating the conveying system being removed from the human        body, and eliminating the limitation to the valve-in-valve        implantation in future.

BRIEF DESCRIPTION OF DRAWINGS

FIGS. 1a-1c are schematic diagrams illustrating an embodiment of thepresent application.

FIGS. 2a-2f are schematic diagrams illustrating multiple embodiments ofthe present application; FIGS. 2g-2j are schematic diagrams illustratinga conveying mode of the present application; FIG. 2k is a partialenlarged view of FIG. 2j ; and FIG. 2l is a schematic diagramillustrating another embodiment of the present application.

FIGS. 3a-3e are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 4a-4f are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 5a-5d are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 6a-6e are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 7a-7d are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 8a-8d are schematic diagrams illustrating multiple embodiments ofthe present application.

FIGS. 9a-9f are schematic diagrams illustrating multiple embodiments ofthe present application, wherein FIG. 9b is a sectional view of FIG. 9a.

DETAILED DESCRIPTION

In order to make the objectives, the technical solutions and theadvantages of the present application more apparent and betterunderstood, the present application will be described in more details byreferring to the accompanying figures and the embodiments.

In the present application, the distal end refers to the end far awayfrom the cardiac apex, and the proximal end refers to the end near tothe cardiac apex.

Embodiment 1

For a long time, large valve manufacturers, whether Edwards Corporationor Medtronic Corporation, all achieve a sufficient anchoring force ofthe supporting frame by increasing the radial expansion ratio of thesupporting frame to the valve annulus, which has already been widelyapplied and become a common view in the field of aortic valveintervention and replacement, and in the field of pulmonary valveintervention and replacement (generally, 10%-15% is the ideal perimeterexpansion ratio). Moreover, subsequently, both Jenavalve Corporation andSymetic Corporation applied the valve leaflet clamping mechanism to theproducts, which still has a certain expansion ratio for the valve of thepatient. However, because the physiological structure and thepathological mechanism of the atrioventricular valve (including themitral valve and the tricuspid valve) are complicated, it is quitedifficult to accurately position and fix the products. Currently, forthe technique of atrioventricular valve intervention and replacement,corporations like Edwards Corporation, Medtronic Corporation and TiaraCorporation, without exception, are required to provide a certain radialexpansion ratio to satisfy the demand of anchoring. Although they employvalve leaflet clamping to improve anchoring effect, the radial expansionratio is just slightly reduced. In general, the conventional anchoringtechniques mostly rely on the supporting force exerted on theatrioventricular valve annulus by the supporting frame. Doctors usuallyselect a valve specification larger than the autogenous atrioventricularvalve annulus of the patient to conform to the contour of the mitralvalve tissue. The huge supporting frame itself not only affects theoutflow tract, but also easily presses the surrounding tissues, andfurther blocks the blood flow in the left ventricular outflow tract. Asfor the mitral valve replacement, the supporting frame specification isso large that the anterior valve of the mitral valve is easily pushedtoward the left ventricular outflow tract. The valve leaflet clamping,which is provided and introduced to fix the anterior valve of the mitralvalve, makes the releasing steps extremely complicated and be influencedby the calcification degree of the valve leaflet, which affects thesuccess rate of the operation. Furthermore, in the prior art thesupporting frame portion located in the atrium mostly employs thelattice form, the huge supporting force of which easily presses theheart tissue, and which cannot completely conform to the non-uniformcontour of the atrial wall or of the native valve annulus of thepatient. Those defects are frequently reported in the clinical reportsof the above technologies.

Therefore, the present application provides a novel heart valveprosthesis that can solve the above problems. In an embodiment, as shownin FIGS. 1a-1c , a heart valve prosthesis 100 anchored to aninterventricular septum is provided for tricuspid valve intervention andreplacement treatment, wherein the heart valve prosthesis comprises avalve supporting frame 110 and a fixing device 113; the valve supportingframe 110 comprises a valve stitching section 112 and an artificialvalve 120; the valve stitching section 112 is a tube-like latticestructure; the artificial valve 120 is fixedly connected to the valvestitching section 112; the fixing device 113 comprises a fixing andsupporting section 114 and a fixing member 115; one end of the fixingand supporting section 114 is connected to a proximal end portion of thevalve stitching section 112, and the other end of the fixing andsupporting section 114 is connected to the interventricular septum 183of the patient by the fixing member 115, to support the heart valveprosthesis 100 and limit the axial movement of the heart valveprosthesis 100. The heart valve prosthesis 100 further comprises a ring111; the ring 111 is connected to the valve stitching section 112, andin a free state, the ring 111 is located in the atrium of the patientand clings to the native valve annulus 180 of the patient. In the designof most of the products in the prior art, the valve annulus is supportedby a supporting frame; what different from the prior art are that, inthe present application, the fixing and supporting section 114 is fixedto the interventricular septum 183 of the patient by the fixing member115, and such an anchoring mode enables the valve supporting frame 110to obtain a anchoring force large enough, without radially dilating thenative valve annulus of the patient. The fixing and supporting section114 is an extension of the proximal skeleton of the valve stitchingsection 112, and the fixing and supporting section 114 is rigid. In sucha design, it is considered that the whole apparatus is supported in thetarget position by the fixing device 113, and the rigidity design mayensure the anchoring function. The distal skeleton of the valvestitching section 112 is provided with an extension section 1121, whichenables the supporting frame to be controllably released, to improve thepositioning accuracy.

In an embodiment, as shown in FIGS. 2a and 2b , the fixing andsupporting section 114 is formed by a plurality of rods. One end of eachof the plurality of rods is connected to the valve stitching section112, and the other ends of the plurality of rods are mutually connectedand are connected to the interventricular septum of the patient by thefixing member 115. The fixing and supporting section 114 is a triangularstructure, the fixing and supporting section 114 is provided with acurved section 1140, thereby enabling the proximal end portion of thefixing and supporting section 114 to cling to the interventricularseptum of the patient. The contact part of the fixing and supportingsection 114 and the interventricular septum 183 of the patient is astraight line section (as shown in FIG. 2k ). Such a design can increasethe contact area between the fixing and supporting section 114 and theinterventricular septum 183 of the patient to the utmost extent, therebyenhancing the anchoring effect. The fixing member 115 is an anchoringneedle, and the distal portion of the anchoring needle 115 ispre-shaped. The needle point portion of the anchoring needle 115 ispre-shaped to be spiral, circular or arcuate, and the needle pointportion of the anchoring needle 115 has a plurality of barbs. The tailportion of the anchoring needle 115 is provided with a stopper 1150, andthe diameter of the stopper 1150 is greater than the needle diameter ofthe anchoring needle 115. The fixing and supporting section 114 iscovered with a film 1141, and the material of the film 1141 comprisesmetal material, polytetrafluoroethylene, polyethylene, polypropylene,terylene or animal-derived material. The needle point portion of theanchoring needle 115 passes through the film 1141 and is inserted intothe heart tissue of the patient.

In another embodiment, as shown in FIGS. 2c and 2d , the fixing andsupporting section 114 is an arcuate structure, and the fixing andsupporting section 114 is provided therein with an enhancing rod 1142.The advantage of such a design is that the rigidity of the fixing andsupporting section 114 is improved, thereby ensuring the anchoringfunction. The fixing member 115 is an anchoring needle, and the distalportion of the anchoring needle 115 is pre-shaped. The needle pointportion of the anchoring needle 115 is pre-shaped to be a combination ofarc line and straight line, or to be branched double hooks, and theneedle point portion of the anchoring needle 115 has one barb. The tailportion of the anchoring needle 115 is provided with a stopper 1150. Thefixing and supporting section 114 is provided with an opening 1143, andthe needle point portion of the anchoring needle 115 passes through theopening 1143 and is inserted into the heart tissue of the patient. Thediameter of the stopper 1150 is greater than the aperture of the opening1143.

In another embodiment, as shown in FIGS. 2e-2f , the fixing andsupporting section 114 is a net-like structure. The fixing member 115 isan anchoring needle, the distal portion of the anchoring needle 115 ispre-shaped, and the needle point portion of the anchoring needle 115 ispre-shaped to be a three-dimensional bent shape or a multi-sectionedbent shape. The needle point portion of the anchoring needle 115 is notprovided with any barbs, and the tail portion of the anchoring needle115 is provided with a stopper 1150. The fixing device 113 comprises afixing member pushing system 116, and the fixing member pushing system116 pushes the fixing member 115, so that one end of the fixing andsupporting section 114 is fixed on the interventricular septum of thepatient. The fixing member pushing system 116 comprises a guide rail1161 and a mandril 1162; the guide rail 1161 is fixedly provided on thefixing and supporting section 114; the ends of the guide rail 1161 havea necking; the anchoring needle 115 and the mandril 1162 are providedwithin the guide rail 1161; by operating the mandril 1162, the needlepoint portion of the anchoring needle 115 passes through the guide rail1161 and is inserted into the interventricular septum of the patient;and the diameter of the stopper 1150 is greater than the aperture of thenecking. After it is confirmed that the anchoring effect of theanchoring needle 115 is ideal, the mandril 1162 is withdrawn from thehuman body.

In an embodiment, as shown in FIGS. 2g-2k , a conveying conduit 190loaded with the heart valve prosthesis 100 is introduced via a minimallyinvasive incision in the right atrial wall to the tricuspid valveannulus. Operate the conveying conduit 190 gradually, so that the fixingdevice 113 can be firstly released; and continue operating the conveyingconduit 190, so that the valve stitching section 112 is partiallyreleased, till the ring 111 is released. At this point, the valvestitching section 112 has not been completely detached from theconveying conduit 190, so the process is reversible. The ring 111 ispositioned by the tricuspid valve annulus, and completely releases thevalve stitching section 112 after being positioned. The fixing device113 comprises a fixing member pushing system 116, and the fixing memberpushing system 116 comprises a guide rail 1161 and a mandril (notlabeled). The ends of the guide rail 1161 have a necking, and theanchoring needle 115 and the mandril are provided within the guide rail1161. Through operating the mandril, the needle point portion of theanchoring needle 115 passes through the guide rail 1161 and is insertedinto the interventricular septum of the patient. The diameter of thestopper 1150 is greater than the aperture of the necking. The guide rail1161 is connected to the fixing and supporting section 114 by adetachable connection (the connection mode may adopt well-knowntechniques, such as rope and slipknot), and after it is confirmed thatthe anchoring effect of the anchoring needle 115 is ideal, by removingthe detachable connection, the fixing-member pushing system 116(comprising the guide rail 1161 and the mandril) and the conveyingconduit 190 may be withdrawn from the human body. The advantage of sucha design is that the volume of the implant can be reduced, therebylowering the risk of thrombosis.

In another embodiment, as shown in FIG. 2l , the stopper 1150 isprovided with a connector 1151, and the connector 1151 is a wire-shapedmember. One end of the connector 1151 is connected to the fixing andsupporting section 114, and the other end of the connector 1151 isconnected to the stopper 1150. Such a design mainly can ensure that theimplanting instrument is detachably connected with the pushing system,thereby improving the accuracy of the needle inserting, and preventingthe anchoring needle from deviating from the predetermined needleinserting point.

Embodiment 2

In an embodiment, as shown in FIGS. 3a and 3b , a heart valve prosthesis200 anchored to an interventricular septum is provided for mitral valveintervention and replacement treatment. The heart valve prosthesiscomprises a valve supporting frame 210 and a fixing device 213; thevalve supporting frame 210 comprises a valve stitching section 212 andan artificial valve (not shown); the artificial valve is fixedlyconnected to the valve stitching section 212; the fixing device 213comprises a fixing and supporting section 214 and a fixing member 215;one end of the fixing and supporting section 214 is connected to aproximal portion of the valve stitching section 212, and the other endof the fixing and supporting section 214 is connected to theinterventricular septum of the patient by the fixing member 215, tosupport the heart valve prosthesis 200 and limit the axial movement ofthe heart valve prosthesis 200. The heart valve prosthesis 200 furthercomprises a ring 211, and the ring 211 is connected to the valvestitching section 212. In a free state, the ring 211 is located in theatrium of the patient and clings to the native valve annulus 280 of thepatient.

In an embodiment, as shown in FIG. 3c , the fixing and supportingsection 214 includes a plurality of rods 2123, and one end of each ofthe plurality of rods 2123 is formed by the extended partial rods in theproximal skeleton of the valve stitching section 212. For example, theplurality of rods 2123 are the extended wave peaks of the zigzag-formwave in the lattice structure of the valve stitching section 212, andthe other end of each of the plurality of rods 2123 is connected to theinterventricular septum of the patient by the fixing member 215. Thefixing and supporting section 214 and the fixing member 215 are anintegral structure, and the fixing member 215 is a sharp structure atthe ends of the rods 2123. The rods 2123 are provided with a curvedsection 2140, so that the sharp structure of the rods 2123 can beinserted into the interventricular septum of the patient.

In another embodiment, as shown in FIG. 3d , the fixing and supportingsection 214 is formed by partial rods 2123 of the proximal skeleton ofthe valve stitching section 212; the rods 2123 are disposed between theneighboring zigzag-form waves or between the neighboring wave-shapedstructures in the lattice structure of the valve stitching section 212,and the rods 2123 are provided with a strengthening wave 2124therebetween, to intensify the transverse supporting force between therods 2123. The fixing and supporting section 214 and the fixing member215 are an integral structure, and the fixing member 215 is one or morebarbs. The fixing and supporting section 214 is provided with a curvedsection 2140, to enable the proximal portion of the fixing device 213 tocling to the interventricular septum of the patient, so that the barbcan be inserted into the interventricular septum of the patient. Asshown in FIG. 3e , on the circumferential circular arc where the outeredge of the valve stitching section 212 is located, the largest arclength that is formed by the connection points of the plurality of rods2123 and the valve stitching section 212 is greater than or equal to aquarter of the perimeter of the valve stitching section 212. Theadvantage of such a design is that the fulcrum of the fixing andsupporting section 214, which is disposed on the valve stitching section212, can provide sufficient supporting strength and rigidity, therebyavoiding incline of the valve stitching section 212.

In an embodiment, as shown in FIGS. 4a and 4b , the ring 211 and thevalve stitching section 212 are an integral structure; the ring 211 hasa skeleton 2111 made of a shape memory alloy; the skeleton 2111 isentirely covered with a film 2112; the skeleton 2111 includes aplurality of supporting rods; the supporting rods are formed by partialrods of the valve stitching section 212, and the width of the supportingrod is 0.4 mm. In a cross-section perpendicular to the central axis ofthe artificial valve, the projection of the ring 211 is a D-shaped ringstructure, and the valve stitching section 212 is disposed in the ring211. More preferably, the supporting rod 2111 is a wave-shapedstructure. The advantage of such a design is that the flexibility of theskeleton 2111 is improved, so that the ring 211 may conform to thenon-uniform contour of the atrial wall or of the native valve annulus ofthe patient, thereby improving the leak resistance effect.

In the product in the prior art, the supporting frame disposed in theatrium mostly employs the lattice form, and the huge supporting force ofthe supporting frame easily presses the heart tissue, and the leakresistance effect is unsatisfying. What different from the supportingframe in the prior art are that, the ring 211 of the present applicationis disposed in the atrium of the patient and clings to the native valveannulus of the patient, and the ring 211 may conform to the non-uniformcontour of the atrial wall or of the native valve annulus of thepatient, thereby improving the leak resistance effect. In an embodiment,as shown in FIG. 4c , in a longitudinal section parallel to a centralaxis of the artificial valve, the projection of the ring 211 is adisk-like structure. As shown in FIGS. 4d-4f , the ring 211 has askeleton 2111 made of a shape memory alloy; the skeleton 2111 isentirely covered with a film 2112; and the material of the film 2112comprises metal material, polytetrafluoroethylene, polyethylene,polypropylene, terylene or animal-derived material. The skeleton 2111 isa wave-shaped structure, a saw-shaped structure or a lattice structurethat is formed by winding a metal memory material wire. The diameter ofthe metal memory material wire (for example, a nickel titanium alloywire) is 0.3 mm. The ring 211 and the valve stitching section 212 aremade separately and independently and then connected to form an integralstructure by stitching with a suture.

Embodiment 3

In an embodiment, as shown in FIGS. 5a-5c , a heart valve prosthesis 300anchored to an interventricular septum is provided for tricuspid valveintervention and replacement treatment, wherein the heart valveprosthesis comprises a valve supporting frame 310 and a fixing device313; the valve supporting frame 310 comprises a valve stitching section312 and an artificial valve (not shown); the artificial valve is fixedlyconnected to the valve stitching section 312; the valve stitchingsection 312 is a tube-like wave-shaped structure; the fixing device 313comprises a fixing and supporting section 314 and a fixing member 315;the fixing and supporting section 314 is an inverted cone-shapedstructure; the fixing and supporting section 314 includes a plurality ofrods or wires; one end of the fixing and supporting section 314, whichhas a larger diameter, is connected to the proximal end of the valvestitching section 312 through well-known techniques such as stitching,clipping or welding; one end of the fixing and supporting section 314,which has a smaller diameter, is provided with a connecting rod 317; theconnecting rod 317 is rigid; one end of the connecting rod 317 isconnected to one end of the fixing and supporting section 314; theproximal portion of the connecting rod 317 is provided with the fixingmember 315, and in a free state, the fixing member 315 is fixed on theinterventricular septum 383 of the patient, to support the heart valveprosthesis 300 and limit the axial movement of the heart valveprosthesis 300. The heart valve prosthesis 300 further comprises a ring311, and the ring 311 is connected to the valve stitching section 312.

The proximal portion of the connecting rod 317 is a hollow tube, and thetube wall is provided with an opening 3170. The furthest distal end ofthe fixing member 315 is sharp, and the distal portion of the fixingmember 315 is pre-shaped. The distal end portion of the fixing member315 is pre-shaped to be one of or a combination of the following shapes:spiral, circle, arc, a combination of arc and straight line, brancheddouble hooks, three-dimensional bent shape, and multi-section bentshape. The distal end of the fixing member 315 does not have a barb, orhas one or more barbs. In a free state, the furthest distal end of thefixing member 315 protrudes out of the opening 3170 in the hollow tube317 and is inserted into the interventricular septum 383.

The ring 311 is connected to the valve stitching section 312, and in afree state, the ring 311 is disposed in the atrium of the patient andclings to the native valve annulus 380 of the patient. Thecross-sectional area of the ring 311 is greater than the cross-sectionalarea of the native valve annulus 380 (the dotted lines shown in FIGS. 5band 5c ) of the patient, and the ring 311 may conform to the non-uniformcontour of the atrial wall or of the native valve annulus of the patientand does not restrict the contraction function of the atrium. In across-section perpendicular to the central axis of the artificial valve,the projection of the ring 311 is a ring-shaped structure, and thering-shaped structure comprises a circular structure (FIG. 5b ) or anelliptic structure (FIG. 5c ).

In an embodiment, as shown in FIG. 5d , in a longitudinal sectionparallel to a central axis of the artificial valve, the projection ofthe ring 311 is a bowl-like structure, and the bowl opening is supportedwithin the atrium 381 of the patient. The ring 311 has a skeleton 3111made of a shape memory alloy, and the skeleton 3111 is partially coveredwith a film 3112, so as to prevent the ring 311 supported within theatrial wall from blocking the coronary sinus, the superior vena cava andthe inferior vena cava. The material of the film 3112 comprises metalmaterial, polytetrafluoroethylene, polyethylene, polypropylene, teryleneor animal-derived material.

Embodiment 4

In an embodiment, as shown in FIG. 6a , a heart valve prosthesis 400anchored to an interventricular septum is provided for tricuspid valveintervention and replacement treatment. This embodiment is differentfrom embodiment 3 in that, the fixing member 415 is a supporting framehaving two larger end portions and a smaller middle portion, and isformed by a shape memory alloy, and in a free state, the fixing member415 is fixed to the interventricular septum 483.

In an embodiment, what different from the concentric structure of mostof the conventional products are that: in the present application, in across-section perpendicular to the central axis of the artificial valve,the projection of the ring 411 is a circular ring-shaped structure; thevalve stitching section 412 is disposed in the ring 411; and thecross-sectional area of the valve stitching section 412 is less than thecross-sectional area of the native valve annulus 480 of the patient,which prevents the valve stitching section 412 radially dilating thenative valve annulus 480 of the patient. Such a design not only reducesthe influence on the outflow tract after the supporting frame isreleased, and avoids the traction to the protogenetic valve annulus, butalso ensures that the opening area of the valve will not change greatlybecause of the huge difference between the valve annulus of patients,thereby optimizing the performance of the valve, and moreover, themanufacturers may reduce the product specifications, which alleviatesthe goods stocking pressure of the manufacturers. The center of thevalve stitching section 412 and the center of the ring 411 are notcoincident, and the ring 411 is eccentrically arranged relative to thevalve stitching section 412. As shown in FIG. 6b , when the heart valveprosthesis 400 is used for mitral valve intervention and replacement,the central axis of the valve stitching section 412 deviates toward theposterior valve region 485 (shown by dotted lines) of the mitral valveof the patient, which can further reduce the block to the leftventricular outflow tract. As shown in FIG. 6c , when the heart valveprosthesis 400 is used for tricuspid valve intervention and replacement,the central axis of the valve stitching section 412 deviates toward thecuspis medialis region 486 (shown by dotted lines) of the tricuspidvalve of the patient, which facilitates the fixing device clinging tothe target anchoring region, thereby obtaining a more ideal anchoringeffect, and more stable movement of the valve.

In an embodiment, as shown in FIGS. 6d and 6e , the ring 411 and thevalve stitching section 412 are made separately and independently andthen connected to form an integral structure. The skeleton of the valvestitching section 412 is provided with an opening 4123, and the ring 411passes through the opening 4123 and is connected to the valve stitchingsection 412 with a suture 4113. The ring 411 has a skeleton made of ashape memory alloy, and the skeleton is entirely covered with a film. Ina longitudinal section parallel to a central axis of the artificialvalve, the projection of the ring 411 is a disk-like structure. The ring411 is provided with a barb 4114, and when the ring 411 clings to thenative valve annulus of the patient, the barb 4114 is inserted into theautologous tissue of the patient.

Embodiment 5

In an embodiment, as shown in FIGS. 7a and 7b , what different from theabove embodiments are that, the heart valve prosthesis 500 furthercomprises an auxiliary fixing device 518; the auxiliary fixing device518 is a wire or a rod; one end of the auxiliary fixing device 518 isconnected to the valve stitching section 512, and the other end of theauxiliary fixing device 518 is fixed on an atrium tissue of the patient.The advantage of such a design is that displacement or disengagement ofthe implant can be avoided by means of upper and lower locationlimiting, thereby enhancing the anchoring fastness of the implant.

In another embodiment, as shown in FIG. 7c , the auxiliary fixing device518 is a supporting frame having two larger end portions and a smallermiddle portion, and is formed by a shape memory alloy. In a free state,the auxiliary fixing device 518 is fixed on the atrial wall 581. Inanother embodiment, as shown in FIG. 7d , the auxiliary fixing device518 is a tube-like supporting frame, and in a free state, the auxiliaryfixing device 518 is fixed in the superior vena cava 582.

In an embodiment, as shown in FIG. 8a , the heart valve prosthesis 500further comprises an auxiliary stabilizing device 519. The proximal endof the auxiliary stabilizing device 519 is connected to the fixing andsupporting section 514, and the distal end of the auxiliary stabilizingdevice 519 is connected to the valve stitching section 512. In alongitudinal section parallel to a central axis of the artificial valve,the projections of the valve stitching section 512, of the fixing andsupporting section 514 and of the auxiliary stabilizing device 519 areconnected to become a closed structure, which enables the implant to bemore secure in the target position while ensuring the operationconvenience of fixing on one side, thereby preventing the implant fromlosing balance in the body of the patient. As shown in FIG. 8b , inorder to maximize the above balancing effect, the distal end of theauxiliary stabilizing device 519 is connected to the position with themaximum diameter of the valve stitching section 512. In a longitudinalsection parallel to a central axis of the artificial valve, theprojections of the valve stitching section 512, of the fixing andsupporting section 514 and of the auxiliary stabilizing device 519 areconnected to become a triangle. In consideration of the uniformity ofthe length of the compressed fixing and supporting section 514 and thelength of the compressed the auxiliary stabilizing device 519, as shownin FIG. 8c , the auxiliary stabilizing device 519 is designed to be awire or a wave-like rod. In another embodiment, as shown in FIG. 8d ,the proximal end of the auxiliary stabilizing device 519 is connected tothe fixing member 515, and the distal end of the auxiliary stabilizingdevice 519 is connected to the valve stitching section 512.

In another embodiment, as shown in FIG. 9a , an outer surface of thevalve stitching section 512 is further provided with a filling device530. In a cross-section perpendicular to the central axis of theartificial valve 520, as shown in FIG. 9b , the projection of thefilling device 530 is a ring-shaped structure, and the ring-shapedstructure comprises a circular ring structure or a D-shaped ringstructure. The advantage of such a design is that the contact with thenative valve is increased, thereby improving the leak resistance effect.The filling device 530 has a skeleton made of a shape memory alloy, theskeleton is partially or entirely covered with a film, and the filmmaterial comprises metal material, polytetrafluoroethylene,polyethylene, polypropylene, terylene or animal-derived material. Inanother embodiment, as shown in FIG. 9c , the filling device 530 and thering 511 are an integral structure. The proximal skeleton 5120 of thevalve stitching section 512 is partially extended. Such a design enablesthe ring 511 to expand firstly while the proximal end of the valvestitching section 512 remains compressed, which facilitates adjustingthe position of the supporting frame, thereby preventing the proximalend of the supporting frame from stabbing the blood vessel wall due toexpanding in the adjusting process.

In another embodiment, as shown in FIGS. 9d-9f , the distal skeleton ofthe valve stitching section 512 is provided with an extended section5121, and the extended section 5121 and the valve stitching section 512are detachably connected. Such a design ensures that the extendedsection 5121 may be withdrawn from the human body while the supportingframe is ensured to be controllably released, thereby greatly reducingthe implant, reducing the contact and stimulation to the atrium,facilitating the conveying system being removed from the human body, andeliminating the limitation to the valve-in-valve implantation in future.As shown in FIG. 9e , the proximal end of the extended section 5121 isprovided with a hole-like structure 5125; the distal skeleton of thevalve stitching section 512 enters the hole-like structure 5125 in astaggered way; the distal skeleton of the valve stitching section 512 isprovided with a locking hole 5126, and the locking is realized byinserting a locking rod 5127 into the locking hole 5126. As shown inFIG. 9f , when the locking rod 5127 is pulled out of the locking hole5126, the distal skeleton of the valve stitching section 512 isseparated from the hole-like structure 5125 of the extended section5121, to realize the detaching of the extension section 5121 and thevalve stitching section 512.

Finally, it should be understood that, the above descriptions are merelypreferable embodiments of the present application, and are not intendedto limit the present application. Any modifications, equivalentsubstitutions and improvements that are made within the spirits andprinciples of the present application are all within the protectionscope of the present application.

What is claimed is:
 1. A heart valve prosthesis anchored to aninterventricular septum, comprising a valve supporting frame and afixing device; the valve supporting frame comprises a valve stitchingsection and an artificial valve; the artificial valve is fixedlyconnected to the valve stitching section; the fixing device comprisesonly one fixing and supporting section and a fixing member; one end ofthe fixing and supporting section is connected to a proximal portion ofthe valve stitching section; and another end of the fixing andsupporting section is connected only to the interventricular septum of apatient by the fixing member, to support the heart valve prosthesis andlimit axial movement of the heart valve prosthesis; wherein the heartvalve prosthesis further comprises a ring; the ring is connected to thevalve stitching section; and in a free state, part of the ring is placedin the patient's atrium; wherein in a cross-section perpendicular to acentral axis of the artificial valve, a center of the valve stitchingsection and a center of the ring are not coincident.
 2. The heart valveprosthesis anchored to the interventricular septum according to claim 1,wherein the fixing device comprises a fixing member pushing system; andthe fixing member pushing system is configured to push the fixing memberso that one end of the fixing and supporting section is fixed on theinterventricular septum of the patient.
 3. The heart valve prosthesisanchored to the interventricular septum according to claim 1, whereinthe fixing and supporting section is covered with a film.
 4. The heartvalve prosthesis anchored to the interventricular septum according toclaim 1, wherein the heart valve prosthesis further comprises anauxiliary fixing device; one end of the auxiliary fixing device isconnected to a distal end of the valve stitching section, and anotherend of the auxiliary fixing device is anchored on an atrium tissue. 5.The heart valve prosthesis anchored to the interventricular septumaccording to claim 1, wherein the heart valve prosthesis furthercomprises an auxiliary fixing device; one end of the auxiliary fixingdevice is connected to a distal end of the valve stitching section, andanother end of the auxiliary fixing device is anchored in a blood vesselof the patient.
 6. The heart valve prosthesis anchored to theinterventricular septum according to claim 1, wherein the heart valveprosthesis further comprises an auxiliary stabilizing device; a proximalend of the auxiliary stabilizing device is connected to the fixing andsupporting section; and a distal end of the auxiliary stabilizing deviceis connected to the valve stitching section.
 7. The heart valveprosthesis anchored to the interventricular septum according to claim 1,wherein the heart valve prosthesis further comprises an auxiliarystabilizing device; a proximal end of the auxiliary stabilizing deviceis connected to the fixing member; and a distal end of the auxiliarystabilizing device is connected to the valve stitching section.
 8. Theheart valve prosthesis anchored to the interventricular septum accordingto claim 4, wherein the auxiliary stabilizing device is one of a wireand a rod.
 9. The heart valve prosthesis anchored to theinterventricular septum according to claim 5, wherein the auxiliarystabilizing device is one of a wire and a rod.
 10. The heart valveprosthesis anchored to the interventricular septum according to claim 1,wherein a filling device is arranged on an outer surface of the valvestitching section.